A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01266902
Recruitment Status : Active, not recruiting
First Posted : December 24, 2010
Last Update Posted : February 28, 2018
Information provided by (Responsible Party):
Janssen R&D Ireland

Brief Summary:
The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Rilpivirine Phase 3

Detailed Description:
This is a Phase III, open-label (all people know the identity of the drug), multicenter, roll-over trial to provide continued access to TMC278 to HIV-1 infected patients who were randomized (the study drug is assigned by chance) and treated with TMC278 in the Phase IIb (TMC278-C204 [C204]) or Phase III trials (i.e., TMC278-TiDP6-C209 [C209] or TMC278-TiDP6-C215 [C215]) and who continue to benefit from their antiretroviral treatment, according to the investigator. In addition, information on the long-term safety and tolerability, including resistance data in case of virologic failures, of oral doses of TMC278 25 mg once daily (q.d.) in combination with a background regimen containing 2 N(t)RTIs will be collected. Available efficacy data will also be collected. Approximately 750 HIV-1 infected individuals are expected to participate in this trial. The duration of participation in the study for an individual participant will be 2 to 3 years. The final/withdrawal visit of the Phase IIb or Phase III trials will be the first visit of this trial. Safety and tolerability will be evaluated throughout the trial. Visits and assessments performed should be based on the local, generally accepted standard of care, with visits occurring at least every 6 months. Oral tablets of TMC278 25 mg once daily (q.d.) should be administered together with a meal.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 483 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Trial With TMC278 25 mg q.d. in Combination With a Background Regimen Containing 2 N(t)RTI's in HIV-1 Infected Subjects Who Participated in TMC278 Clinical Trials and Were Still Benefitting From Treatment With TMC278
Actual Study Start Date : February 25, 2011
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Rilpivirine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rilpivirine
Rilpivirine 25 mg once daily
Drug: Rilpivirine
25 mg once daily

Primary Outcome Measures :
  1. The number of participants affected by an adverse event [ Time Frame: Up to 3 years ]
  2. Any Division of AIDS (DAIDS) grade 3/4 rash [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. HIV RNA levels [ Time Frame: Up to 3 years ]
  2. CD4+ cell count [ Time Frame: Up to 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients are HIV-1 infected and were previously randomized to receive TMC278 in a TMC278 clinical trial and completed the protocol-defined treatment period.
  • Patients continue to benefit from treatment with TMC278 in the opinion of the investigator.
  • Patient can comply with the current protocol requirements.
  • The patient's general medical condition, in the investigator's opinion, does not interfere with participation in the trial.

Exclusion Criteria:

  • Use of disallowed concomitant therapy.
  • Females of childbearing potential who are pregnant, or without the use of effective birth control methods, or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or last intake of TMC278).
  • Non-vasectomized heterosexually active male patients without the use of effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or after last intake of TMC278).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01266902

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Beverly Hills, California, United States
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Sponsors and Collaborators
Janssen R&D Ireland
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland

Additional Information:
Responsible Party: Janssen R&D Ireland Identifier: NCT01266902     History of Changes
Other Study ID Numbers: CR017434
TMC278-TiDP6-C222 ( Other Identifier: Janssen R&D Ireland )
2010-021209-18 ( EudraCT Number )
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen R&D Ireland:
HIV-1 Infection

Additional relevant MeSH terms:
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents